Job Description

We are currently seeking a Biostatistician to be responsible for the preparation of PK, Statistical Analysis, and Statistical Reports for BA/BE and Phase I studies for various Regulatory submissions. Within the role you will:

  • Provide statistical input and sample size calculations during protocol design
  • Provide statistical/programming inputs for CRF design and review
  • Generate randomization lists
  • Prepare statistical analysis plans
  • Perform blinded statistical review to check for data discrepancies
  • Generate statistical analysis data sets
  • Develop programming requirements documents for SAS programmers
  • Perform data analysis and prepare statistical reports
  • Generate data listings, tables, and graphs
  • Develop programs for quality control of analysis programs
  • Provide Statistical training to SAS programmers and knowledge sharing to statisticians
  • Prepare integrated summaries of efficacy and safety, and answer regulatory queries
  • Understand and comply with all SOPs
  • Preparation of appendices in eCTD format

Desirable Skills and Experience

  • 3 – 5 years of experience in BA/BE Studies

Bangalore, India

MSc Statistics


Generics Development

Full Time

12 Jul 2022